NCT02512588

Brief Summary

This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

July 23, 2015

Last Update Submit

January 14, 2019

Conditions

Idiopathic HypersomniaNarcolepsy Without Cataplexy

Outcome Measures

Primary Outcomes (1)

  • Efficacy Epworth Sleepiness Scale

    Epworth Sleepiness Scale

    After 14 days per treatment

Secondary Outcomes (1)

  • Efficacy Maintenance of Wakefulness Test

    After 14 days per treatment

Other Outcomes (4)

  • Pharmacokinetics (Cmax)

    Selected Days 14, 35, and 56

  • Pharmacokinetics (Tmax)

    Selected Days 14, 35, and 56

  • Pharmacokinetics (T½)

    Selected Days 1, 14, 31, 35, 42, and 56

  • +1 more other outcomes

Study Arms (2)

BTD-001

EXPERIMENTAL
Drug: BTD-001

Placebo

EXPERIMENTAL
Drug: Placebo

Interventions

BTD-001DRUG
BTD-001
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets ICSD-3 criteria for IH or Narcolepsy Type 2 and not undergoing pharmacologic treatment for the condition
  • Usual nightly total sleep at least 6 hours as single major rest period without naps
  • Epworth Sleepiness Scale of 10 or greater
  • Males or females age 18 to 65 years

You may not qualify if:

  • Any disorder causing hypersomnia other than IH or Narcolepsy Type 2
  • Usual bedtime later than midnight
  • Seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years
  • Beck Depression Inventory score greater than 19
  • Beck Anxiety Inventory score greater than 15
  • Significant history of or current suicidal ideation or behavior
  • BMI less than 18 kg/m2 or greater than 39 kg/m2
  • Positive toxicology screen or breathalyzer test
  • Clinically significant abnormal findings on safety assessments
  • Any significant medical or psychiatric disease or any condition that would put the patient at risk by participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Stanford Medicine Sleep Center

Palo Alto, California, 94304, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

Empire Clinical Research

Upland, California, 91786, United States

Location

REM Sleep Medicine, Colorado Sleep Institute

Boulder, Colorado, 80301, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, 33707, United States

Location

Emory University School of Medicine Emory Sleep Center

Atlanta, Georgia, 30329, United States

Location

NeuroTrials Research Inc

Atlanta, Georgia, 30342, United States

Location

SleepMed of Central

Macon, Georgia, 31201, United States

Location

Kentucky Research Group,

Louisville, Kentucky, 40218, United States

Location

The Center for Sleep and Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

NeuroCare Center for Sleep

Newton, Massachusetts, 02459, United States

Location

Neurological Associate

Maplewood, Minnesota, 55109, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Community Research Management Assoc.

Cincinnati, Ohio, 45255, United States

Location

Lynn Institute

Oklahoma City, Oklahoma, 73112, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Future Search Trials of Neurology

Austin, Texas, 78731, United States

Location

Houston Sleep Center

Houston, Texas, 77063, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Idiopathic Hypersomnia

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Lyndon Lien, PhD

    Balance Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 31, 2015

Study Start

September 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(23)